Macrodantin

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Infovoldik Infovoldik (PIL)
13-05-2024
Toote omadused Toote omadused (SPC)
13-05-2024

Toimeaine:

Nitrofurantoin

Saadav alates:

Pfizer Australia Pty Ltd

Klass:

Medicine Registered

Infovoldik

                                MACRODANTIN
®
 
_Nitrofurantoin_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
 Please read this leaflet carefully
before you start taking
MACRODANTIN. This leaflet
answers some common questions
about MACRODANTIN. It does not
contain all the available information
and it does not take the place of
talking to your doctor or pharmacist.
 All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the expected benefits it will
have for you.
 Take MACRODANTIN as instructed
and follow the advice given in this
leaflet.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
 Keep this leaflet with the medicine.
You may need to read it again.
WHAT MACRODANTIN
IS USED FOR
 MACRODANTIN is used to treat
infections of the urinary system
caused by bacteria, for example,
bladder infections.
 MACRODANTIN is an antibiotic
which belongs to a group of
medicines called nitrofurans. It
works by killing or stopping the
growth of the bacteria and other
organisms causing these infections.
 Your doctor may have prescribed
MACRODANTIN for another
reason. Ask your doctor if you have
any questions about why
MACRODANTIN has been
prescribed for you.
 These medicines are only available
with a doctor's prescription.
BEFORE YOU TAKE
MACRODANTIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MACRODANTIN IF:
1. you have an allergy to
MACRODANTIN or any other
nitrofuran, or to any of the
ingredients listed at the end of
this leaflet. Symptoms of an
allergic reaction include skin
rash, itching, difficulty with
breathing, fever and chills.
2. you have severe kidney problems.
3. you are pregnant and close to
giving birth.
INFANTS UNDER ONE MONTH OF AGE
SHOULD NOT BE GIVEN
MACRODANTIN.
Do not use MACRODANTIN if the
packaging is torn or shows signs of
tampering.
Do not use it after the expiry date
(EXP) printed on the pack.
_BEFORE YOU START TAKING IT_
YOU MUST TELL YOUR DOCTOR IF:
1. you are pregnant or intend to
become pregnant. Your doctor
will d
                                
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                                Version: pfpmacrc10513 
Page 1 of 9 
Supersedes: pfpmacrc10413 
PRODUCT INFORMATION 
MACRODANTIN

 CAPSULES 50 MG AND 100 MG 
(NITROFURANTOIN MACROCRYSTALS) 
NAME OF THE MEDICINE 
Nitrofurantoin has the following chemical structure: 
 
Nitrofurantoin has  the following molecular formula, molecular weight and Chemical Abstracts 
Service (CAS) Registry number:  C
8
H
6
N
4
O
5
, 238.2, CAS-67-20-9. 
DESCRIPTION 
Nitrofurantoin,  1-(5-nitrofurfurylideneamino)  hydantoin,  is  a  synthetic  antibacterial  nitrofuran 
derivative.    It  occurs  as  lemon  yellow  crystals,  or  fine  powder,  and  is  very  slightly  soluble  in 
water or alcohol.  However, solubility of the drug in water and urine increases with rises in pH.
 
The  sodium  salt  occurs  as  an  orange  coloured  powder  and  is  soluble  in  water.   Nitrofurantoin 
darkens on exposure to light or to alkali and is decomposed upon contact with metals other than 
stainless steel  or aluminium.   In view of this, the drug should be dispensed in amber coloured 
bottles. 
NOTE:    MACRODANTIN  (nitrofurantoin  macrocrystals)  is  a  larger  crystal  form  of 
nitrofurantoin.    The  absorption  of  MACRODANTIN  is  slower  and  the  excretion  of 
MACRODANTIN  is  somewhat  less,  when  the  two  are  compared.    The  reduced  incidence  of 
gastrointestinal  intolerance  with  MACRODANTIN  is  probably  due  to  delayed  and  decreased 
absorption;  this  however  does  not  significantly  reduce  clinical  effectiveness.    A  number  of 
patients who cannot tolerate nitrofurantoin tablets can take MACRODANTIN capsules without 
nausea. 
PHARMACOLOGY 
MICROBIOLOGY 
MACRODANTIN is bacteriostatic at low concentrations (1:100,000 to 1:200,000) an
                                
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